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AI agent for clinical data managers

Protocol Amendment Database Impact Agent

Update the database to match an amendment with every change mapped and tested

Quality controlIT and development
See how it worksGet access
Protocol Amendment Database Impact Agent: what goes in, what the agent does and what you get

What it does

A protocol amendment adds a visit and changes a lab window, and weeks later someone notices the forms and checks were not updated. This agent compares the old and new protocol text and lists every change: new or removed visits, assessments, windows, eligibility criteria, lab ranges and dosing rules. It maps each change to its place in the database: case report forms, edit checks, coding and derivations. It drafts the changes to the specification and the edit checks, and tests them in a test environment with test data, including edge cases at the window boundaries. If a test fails, it fixes and retests. The manager approves migration of the changes to production. Edge case: an existing subject is mid-study, so the agent drafts how old data will map to the new version.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
ApprovedYes, continueApprovedNo 1 STARTS WHEN Protocol amendment approved 2 USES A TOOL Compare old and new protocols and list changes 3 DOES Map each change to forms, edit checks, coding andderivations 4 DOES Draft the specification and edit check changes 5 YOU APPROVE Manager approves the specification changes 6 USES A TOOL Build the changes in the test environment 7 USES A TOOL Run test cases including window boundaries andexisting subjects 8 CHECKS THE RESULT Do all tests pass? If not: fix the failing change in the draft and run thetests again. Back to step 4. 9 DOES Draft the migration plan for subjects alreadyenrolled 10 YOU APPROVE Manager approves migration to production 11 RESULT Amendment impact report and migration plan
Read the steps as a list
  1. Protocol amendment approved
  2. Compare old and new protocols and list changes
  3. Map each change to forms, edit checks, coding and derivations
  4. Draft the specification and edit check changes
  5. Manager approves the specification changesThe agent waits here for your OK.
  6. Build the changes in the test environment
  7. Run test cases including window boundaries and existing subjects
  8. Do all tests pass?If not: fix the failing change in the draft and run the tests again. Back to step 4.
  9. Draft the migration plan for subjects already enrolled
  10. Manager approves migration to productionThe agent waits here for your OK.
  11. Amendment impact report and migration plan

How it decides

It maps each protocol change to the database item it affects and requires a passing test for each before it recommends migration.

  • List every visit, assessment and window change
  • Test each edit check at the boundary and one step either side
  • Require a data mapping plan for enrolled subjects
  • Treat any eligibility change as a priority review

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Specification template
  • Test case format
  • Edit check naming
  • Subject mapping rules
  • Sponsor review step

What keeps you in control

It always asks you first

  • Manager approves specification changes
  • Manager approves production migration

Hard limits

  • Test everything in a test environment, never in production
  • Never migrate without approval

It stops when

  • Done: all tests pass and the migration plan is approved
  • Stop: the amendment is ambiguous and the sponsor must clarify

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensAmendment 3 added a week-6 ECG and widened the lab window from 3 to 5 days. The agent listed 9 changes and mapped them to 4 forms and 6 edit checks. In testing, the window check failed on day 5 because the old limit was still in a derivation, so the check failed. It fixed the derivation and the tests passed. The plan covered 112 enrolled subjects, and the manager approved.

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